Gilenya 0.5 mg
Gilenya 0.5 mg is a medicine authorised by Swissmedic under authorisation number 60916. The authorisation holder is Novartis Pharma Schweiz AG. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 03 January 2011 and the authorisation is valid without a time limit. ATC code L04AE01 places the medicine in the group Immunosuppressants.
| Authorisation number | 60916 |
|---|---|
| Name | Gilenya 0.5 mg |
| Full name | Gilenya 0.5 mg, Kapseln |
| Authorisation holder | Novartis Pharma Schweiz AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | L04AE01 |
| First authorisation | 03 January 2011 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Gilenya 0.5 mg, Kapseln | B | 03 January 2011 |
| 2 | Gilenya 0.25 mg, Kapseln | B | 10 January 2019 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 28 | Kapsel(n) | L04AE01 | 01.99.0. | B |
| 2 | 98 | Kapsel(n) | L04AE01 | 01.99.0. | B |
| 3 | 7 | Kapsel(n) | L04AE01 | 01.99.0. | B |
| 4 | 28 | Kapsel(n) | L04AE01 | 01.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Gilenya 0.5 mg authorised in Switzerland?
Yes. Gilenya 0.5 mg is authorised by Swissmedic under authorisation number 60916, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Gilenya 0.5 mg have?
Gilenya 0.5 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Gilenya 0.5 mg?
The authorisation holder is Novartis Pharma Schweiz AG. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.